510(k) Report

Devices descending from K003391

174 later devices reach Osteonics Alumina C-Taper Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+6K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+6K191831MobiliT CupCorin U.S.A. Limited20203—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+6K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+6K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+6K131952Corin Metafix Hip StemCorin USA20134—
+6K131986Corin Minihip StemCorin USA20133—
+6K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+7K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+7K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+7K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+7K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+7K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+7K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+7K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+7K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+7K130634Corin Metafix Hip StemCorin USA20135—
+7K121563Corin Trifit TS HipCorin USA2012101
+7K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+8K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+8K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+8K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+8K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+8K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+8K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+8K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+8K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+8K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+8K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+8K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+8K171249Entrada™ hip stemOrtho Development Corporation20172—
+8K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+8K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+8K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+8K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+9K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+9K251166Mfinity Femoral SystemMedacta International S.A.20250—
+9K251052Trivicta® Hip StemOrtho Development Corp.20250—
+9K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+9K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+9K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+9K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+9K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+9K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+9K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+9K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+9K211703Insignia Hip StemStryker Orthopaedics20217—
+9K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+9K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+9K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+9K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+9K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+10K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+10K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+10K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+10K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+10K210678implaFit® hip stemsImplantcast GmbH20223—
+10K221104Actera™ hip systemConformis, Inc.202211
+11K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+11K252401implaFit® short stemsImplantcast GmbH20260—
+11K252067Velora Acetabular SystemRestor3D, Inc.20250—
+11K232371Actinia® hip stemsImplantcast GmbH20231—
+11K231178ACTERA™ hip systemConformis, Inc.20230—